NATIONAL COORDINATOR FOR AQUACULTURE NEW ANIMAL DRUG APPLICATIONS (NADAs)

Kent SeaTech Corporation, the new United States representative GB Research, Inc., submitted to the Center for Veterinary Medicine (CVM) a research and development plan for amoxicillin on March 27, 2002.

Axcentive bv through its U.S. representative held a meeting with CVM on October 31, 2001 to discuss the genotoxicity concerns that CVM has on marker residue of its chloramine-T product Halamid®. Resolution to mammalian safety issues is possible if Axcentive bv provides acceptable evidence that p-TSA is not genotoxic.

On April 23, 2002, CVM accepted an analytical method for para-toluenesulfonamide (p-TSA) for tissues of multiple fish species and depletion of p-TSA from fish tissues from the Upper Midwest Environmental Sciences Center (UMESC).

On March 11, 2002, CVM granted an INAD exemption to Syngenta Crop Protection, Inc. for their diquat dibromide product.

CVM accepted as supporting efficacy data for treatment of external parasitic infestations in fish on July 18, 2001 and target animal safety data for a variety of fish exposed to hydrogen peroxide on October 4, 2001.

On May 15, 2001, CVM accepted residue depletion studies for walleye and northern pike fed oxytetracycline medicated feed and established zero withdrawal times in juvenile northern pike and juvenile walleye at water temperatures down to 14°C and 16°C, respectively.

On October 5, 2001, UMESC submitted a response to CVM regarding data to support human food safety technical section for an analytical method for oxytetracycline in the edible tissue of fish used in residue depletion studies.

On May 21, 2002, CVM accepted the Public Master File for the use of oxytetracycline immersion for skeletal marking of fry and fingerling finfish.

The Upper Midwest Environmental Sciences Center (UMESC) obtained funding for an oxytetracycline environmental assessment from the Wallop-Breaux Sport Fish Restoration Funds on July 25, 2001. The project includes measurement of oxytetracycline in water and sediment in and around a hatchery with a typical treatment for a disease episode.

In September 2001, the Multi-State Conservation Grant Program indicated it funded UMESC to develop: (1) a model to infect fish with external columnaris disease, (2) data toward oxytetracycline immersion therapy, and (3) a determinative analytical method for the marker residue for AQUI-S™.

In September 2001, the Multi-State Conservation Grant Program indicated it funded a study at Arkansas State University on the environmental fate and effect of potassium permanganate.

Data gap meeting with CVM held March 14, 2002

Survey of current IAFWA Project states for unmet label claim needs initiated December 27, 2001

Compilation of state fish production initiated December 28, 2001

Celebration Luncheon on achievements planned for September 18, 2002

Letter to CVM regarding progress and impediments sent March 6, 2002

Prioritization and assessment of the major unmet label claim needs for the control of external bacterial infections on cool water and warm water species on April 7, 2002 and for control of systemic bacterial diseases in fish on April 15, 2002

Clarification of the projected status of label claims on April 8, 2002

! The Joint Subcommittee on Aquaculture Aquaculture Effluents Task Force met on October 17-18, 2001 and January 27, 2002 to discuss the status of EPA’s Effluent Guidelines Plan for aquaculture facilities. A response was written on state effluent permit that would have limited use of INADs and extra label use.

On August 2-3, 2001, nine sponsors or potential sponsors attended a meeting of the Federal-State Aquaculture Drug Approval Partnership Project to learn about the potential for development of their products for United States aquaculture.

! A bill entitled "Minor Use and Minor Species Animal Health Act of 2001" was reintroduced into the House as HR-1956 on May 23, 2001 and as S-1346 into the Senate on August 2, 2001. It was attached to the Bioterrorism bill but was removed before passage. It is now being considered for attachment to the "Animal Drug User Fee Act of 2002."

CVM awarded a contract on the risk assessment of drugs and chemicals used in foreign aquaculture on September 28, 2001 to ICF Consulting with the National Coordinator for Aquaculture New Animal Drug Applications as a subcontractor.

A document on establishment of import tolerances was submitted by the Catfish Farmers of America to the U.S. Food and Drug Administration that stated there should be no difference between domestic and foreign requirements to ensure food safety and fair competition with domestic aquaculture.

 The National Coordinator for Aquaculture New Animal Drug Applications had three publications, presented 12 papers, and wrote 33 reports.

The overall goal of this project is for the National Coordinator for Aquaculture New Animal Drug Applications (National Aquaculture NADA Coordinator) to coordinate activities for investigational new animal drug exemptions (INADs) and new animal drug applications (NADAs) to expedite approval for the use of various drugs in aquaculture. Specific objectives related to that goal are to:

! Serve as an information conduit between INAD/NADA applicants and the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM);

! Identify and encourage prospective INAD participants to become involved in specific investigational studies and NADA approval-related research;

! Seek the support and participation of pharmaceutical sponsors for INAD studies and NADAs and coordinate with INAD/NADA sponsors to achieve CVM approval more quickly;

! Guide prospective and current INAD holders on the format for INAD exemption requests and related submissions to CVM;

! Identify existing data and remaining data requirements for NADA approvals;

! Review, record, and provide information on the status of INADs and NADAs;

! Provide liaison and coordination among all the federal agencies involved in the INAD/NADA process; and

! Provide public education related to training and guidance in obtaining INAD exemptions and pursuing NADA approval.

The National Aquaculture NADA Coordinator provided many information transfers from May 15, 2001 to May 14, 2002and worked to obtain INADs, NADAs, and approvals for a number of drugs that are considered to be of high priority for approval by the public and private aquaculture communities.

Amoxicillin (oral antibacterial)—Status: Early development stage; antimicrobial resistance issue needs to be addressed.

Kent SeaTech Corporation, the new U.S. representative of GB Research, Inc., for the development of its amoxicillin product recently interacted with the National Aquaculture NADA Coordinator to write a research and development plan. That plan was submitted to the Center for Veterinary Medicine (CVM) on March 27, 2002.

The National Aquaculture NADA Coordinator toured the Kent SeaTech Corporation farm in the Coachella Valley, California on January 31, 2002 to learn about striped bass production and the use of amoxicillin.

The Harry K. Dupree Stuttgart National Aquaculture Research Center (HKD-SNARC) has been working on developing efficacy data with isolates of streptococcus.

Chloramine-T (external antibacterial)—Status: Sponsor (Axcentive bv; formerly Akzo Nobel Chemicals, Inc.) committed to INAD/NADA; one label claim close to approval.

Axcentive bv through its U.S. representative held a meeting with CVM on October 31, 2001 to discuss the genotoxicity concerns that CVM has on marker residue of its chloramine-T product, Halamid®. Resolution to mammalian safety issues is possible if Axcentive bv provides acceptable evidence that p-TSA is not genotoxic.

The Upper Midwest Environmental Sciences Center (UMESC) submitted to CVM: (1) data on an analytical method for para-toluenesulfonamide (p-TSA) for tissues of multiple fish species on September 28, 2001 and (2) depletion of p-TSA from tissues of several fish species on October 19, 2001, February 27, 2002, and March 1, 2002. CVM accepted the data on April 23, 2002. When a tolerance is assigned for p-TSA, the residue data in each submission will be used to calculate a withdrawal time. At that time, CVM will evaluate whether the residue data support a residue technical section for chloramine-T in all freshwater-reared finfish.

In September 2001, the Multi-State Conservation Grant Program indicated it will fund UMESC to development of a model to infect fish with external columnaris disease.

Progress on Technical Sections on chloramine-T:

Product Chemistry—The sponsor, Axcentive bv (a 100% daughter company of PNP Holding bv, Barneveld, The Netherlands) is committed to developing the product chemistry technical section and submitting it to CVM into INAD #8086.

Mammalian Safety—The sponsor is addressing this technical section and met with CVM on October 31, 2001 to discuss the resolution of the genotoxicity studies.

Environmental Safety—UMESC wrote an environmental summary in November 2001that was reviewed by outside reviewers. The environmental summary developed on public literature and data will be made available to any chloramine-T sponsors in Public Master File Number 5637. UMESC also developed a proprietary environmental assessment that will be submitted by Axcentive bv to CVM into INAD #8086 after it finishes its review.

Human Food Safety—CVM accepted residue chemistry studies by UMESC for total residue depletion and metabolism of chloramine-T in several species of fish; para-toluene sulfonamide (p-TSA) was established as the major metabolite in fish and declared as a marker residue for chloramine-T in juvenile rainbow trout. CVM accepted simple colorimetric procedure by UMESC for use in efficacy studies for determining chloramine-T concentrations in treatment waters. UMESC completed research to bridge the proposed analytical method for p-TSA with an outdated, labor intensive method previously used to quantify p-TSA in fish tissue. Data developed with the proposed method for p-TSA were similar to analytical data developed with the outdated method indicating that the two methods were successfully bridged. UMESC completed an interagency agreement with CVM’s Office of Research to develop the confirmatory method for p-TSA in fish tissue to satisfy an all fish label claim. This work will be funded with money UMESC originally set aside in another interagency agreement with CVM to conduct work on another drug, benzocaine.

Target Animal Safety—U.S. Fish and Wildlife Service (FWS) at Bozeman, Montana submitted a report to CVM on the toxicity of chloramine-T to salmonids and completed its submission of histopathology report on April 1, 2002. UMESC developed toxicity data on several species of cool water and warm water fish and will submit a final report by July 2002.

Efficacy—Efficacy data requirements are met for chloramine-T for control of mortalities associated with flavobacterial infections on gills of salmonids reared in freshwater at 12 to 20 mg/L for one hour.

Copper Sulfate (external microbicide)—Status: All submissions should soon be completed for control of Ichthyophthirius on catfish in ponds.

Progress on Technical Sections on copper sulfate:

Product Chemistry—Accepted by CVM from the sponsor, Phelps Dodge Refining Corporation.

Mammalian Safety—Accepted by CVM; a Freedom of Information (FOI) summary written by CVM on March 3, 2000.

Environmental Safety—The revised environmental safety technical section for all fish was reviewed by CVM in 2000 and CVM is requiring an additional study. A study at HKD-SNARC addressed the use of copper sulfate in ponds was completed and will be incorporated into a revised EA and submitted to CVM by April 2003.

Human Food Safety—Accepted by CVM; FOI written by CVM on March 3, 2000--no tolerances, regulatory methods, or withdrawal times are needed for finfish treated with copper sulfate.

Target Animal Safety—Additional target animal safety studies with a histopathology component are required for an all fish label claim. HKD-SNARC performed such a study on channel catfish and will submit it to CVM by April 2003.

Efficacy—Accepted by CVM for control of Ichthyophthirius on all fish.

HKD-SNARC also conducted pivotal efficacy studies to control fungi on catfish eggs.

HKD-SNARC is preparing a Freedom of Information Summary (FOI) document on efficacy, target animal safety, and environmental safety for the control of Ichthyophthirius sp. on catfish in ponds by copper sulfate. When the target animal safety and environmental safety technical sections are accepted by CVM, the data requirements will be complete for control of Ichthyophthirius on catfish in ponds.

Cutrine-Plus™ (external microbicide)—Status: No interest by potential sponsor; early development stage, no recent activity.

Diquat Dibromide (external microbicide)—Status: Sponsor made commitment to develop INAD/NADA; early development stage.

Syngenta Crop Protection, Inc., expressed an interest in developing their diquat product for use as a drug in aquaculture. The National Aquaculture NADA Coordinator provided information on diseases, fish species, and potential market from August to October 2001.

The National Aquaculture NADA Coordinator met with Syngenta Crop Protection, Inc. on December 18-19, 2001 in Greensboro, North Carolina to provide information on how to proceed with an INAD that would lead to an NADA approval.

Syngenta Crop Protection, Inc. requested an INAD exemption for their diquat product on March 4, 2002 and was granted an INAD by CVM on March 11, 2002.

The Drug Approval Working Group for the public aquaculture sector expressed an interest in the development of diquat at its meeting on April 4, 2002.

Earth Tec Algicide/Bactericide™ (external microbicide)—Status: No recent activity by sponsor; early development stage.

Enrofloxacin (oral antibacterial)—Status: INADs inactive in the United States because of fluoroquinolone and antimicrobial resistance issues; no sponsor interest.

Erythromycin (oral antibacterial)—Status: Sponsorship needs to be resolved; all technical sections except sponsor product chemistry submitted; risk assessment needed on potential for disease resistance in humans; near NADA approval for bacterial kidney disease in salmonids if can gain sponsor and resolve the antimicrobial resistance issue.

University of Idaho researchers recently submitted to CVM a summary addressing antimicrobial resistance issues by discussing the effects of erythromycin and other antimicrobials on the bacterial load, species composition, and resistance patterns in salmonid gastrointestinal tracts.

A potential sponsor for erythromycin has been identified.

Florfenicol (oral antibacterial)—Status: Sponsor recently allowed the development of florfenicol for approval in U.S.; approved in Canada in August 1997 to control furunculosis in Atlantic salmon. Sponsor will continue to develop data for aquaculture approval for control of diseases in salmonids and catfish but the efforts by the IAFWA Project on florfenicol have been redirected by the IAFWA Drug Approval Working Group (DAWG) to other IAFWA Project drugs.

The florfenicol INAD exemption (INAD 10-697) has been granted by CVM to FWS. The INAD stipulates a 21-day withdrawal period. Efficacy studies are underway at FWS National INAD Office (NIO) mainly on salmonids with analysis of the feed by UMESC. UMESC scientists were trained by Schering-Plough Animal Health personnel on the analytical method for determination of florfenicol in fish feed to support efficacy studies through the INAD held by FWS.

Multi-State Conservation Grant Proposal "Analytical Support of Pivotal Efficacy Trials for Use in Public Fisheries" was funded under the Federal Aid in Sport Fish Restoration Act on May 16, 2001. The proposal provides for analyses of fish feed for florfenicol content from pivotal efficacy trials conducted under the INAD held by FWS. In addition, the proposal includes validation of the analytical method on fish feeds not previously completed by the sponsor and used in pivotal trials.

Discussions on the development of florfenicol were held with CVM and the sponsor at the FWS-INAD Coordination meeting in Bozeman, Montana on August 1-3, 2001.

A proposal was submitted in April 2001 to the Initiative for Future Agriculture and Food Systems to fund studies on both florfenicol and Romet-30® needed for approval in cool and warm water scaled fish to help modest-sized farms diversify for more profitability and efficiency. The proposal was not funded.

A Cooperative Research and Development Agreement (CRADA) between SPAH and USGS was signed on April 10, 2001. UMESC completed a target animal safety study for florfenicol in channel catfish under that CRADA.

Formalin (external microbicide)—Status: Supplemental NADA approved on June 18, 1998 for control of certain fungi on the eggs of all finfish and certain external protozoa and monogenetic trematodes on all finfish. All submissions should soon be completed for control of mortalities associated with fungal infections on all fish.

Natchez Animal Supply Company submitted a supplemental NADA to CVM on June 5, 2001 for its formalin product, Formalin-F®, to control certain fungi on the eggs of all fish and certain external protozoa and monogenetic trematodes on all fish.

Progress on Technical Sections on formalin:

Product Chemistry—Accepted by CVM.

Mammalian Safety—Accepted by CVM.

Environmental Safety—Accepted by CVM.

Human Food Safety—Accepted by CVM.

Target Animal Safety—Accepted by CVM.

Efficacy—Fungal disease model developed for efficacy studies by UMESC.

CVM informally accepted supporting efficacy for control of fungi on salmonids from FWS and UMESC efforts. CVM and UMESC are performing pivotal efficacy studies for control of fungi on salmonids and channel catfish.

Fumagillin (microsporidiosis control)—Status: No recent sponsor activity; several efforts to collect efficacy data in public and private sector; early development stage.

Hydrogen peroxide (external microbicide)—Status: Currently considered as a low regulatory priority drug for use as a fungicide on fish and fish eggs but CVM has encouraged the development of a NADA; three label claims nearing completion for approval.

On July 18, 2001, CVM accepted as supporting efficacy data for treatment of external parasitic infestations in fish.

On October 4, 2001, CVM accepted target animal safety data at concentrations from 50 to 100 mg/L for a variety of fish exposed to hydrogen peroxide from 30 to 60 minutes.

In September 2001, the Multi-State Conservation Grant Program indicated it will fund UMESC to development of a model to infect fish with external columnaris disease.

UMESC has continued to expand its coordination and collaboration to develop additional efficacy data to support the use of hydrogen peroxide by initiating three compassionate INADs. Participation in the three INAD protocols has increased immensely over the past year from 24 INAD cooperators in 2000 to 115 in 2001 and 2002.

Progress on Technical Sections on hydrogen peroxide:

Product Chemistry—Sponsor, Eka Chemicals, Inc., submitted product chemistry technical section on July 12, 1999; additional data are required that the sponsor is committed to provide in summer of 2002.

Mammalian Safety—Accepted by CVM. The FOI summary was written by CVM on March 22, 2000.

Environmental Safety—A model was developed by UMESC to estimate discharged environmental concentrations based on UMESC hatchery survey and a point source dilution model from the U.S. Geological Survey. UMESC wrote an environmental assessment to support an all fish label claim and submitted it to CVM on March 14, 2000, reviewed by a contractor in the winter of 2002, and the final review by CVM to be completed by summer of 2002.

Human Food Safety—Accepted by CVM. The FOI summary was written by CVM on March 22, 2000--no tolerances, regulatory methods, or withdrawal times are needed for finfish and their eggs treated with hydrogen peroxide.

Target Animal Safety—Target animal safety technical section on all fish eggs submitted by UMESC to CVM was accepted for a dose range of 500–1,000 mg/L for northern pike, lake trout, and common carp. A target animal safety technical section on all fish from UMESC was accepted on October 4, 2001 by CVM.

Efficacy—A fungal disease model was developed for efficacy studies with fish by UMESC.

CVM accepted pivotal efficacy data for treatment of salmonid eggs to control mortalities associated with saprolegniasis by a 15-minute treatment at 500 mg/L of hydrogen peroxide; and a 60-minute treatment at 50 mg/L or 30-minute treatment at 100 mg/L of hydrogen peroxide to control mortalities associated with bacterial gill disease on salmonids. CVM accepted the following as supporting data: (1) 60-minute treatments to control mortalities associated with external columnaris disease in yellow perch and (2) treatment of external parasitic infestations in fish.

MelaFixÔ (external microbicide)—Status: Have sponsor; early development stage

Neomycin sulfate (vibriosis control)—Status: No activity on this drug.

Oxytetracycline (OTC, oral antibacterial)—Status: Currently approved for control of certain systemic bacterial diseases in catfish, salmonids, and lobsters and as an oral marking agent in Pacific salmon. Almost all submissions are considered complete for otolith marking on all fish by immersion and for control of mortalities associated with systemic columnaris disease in selected salmonids and systemic coldwater disease in all salmonids.

On May 15, 2001, CVM accepted residue depletion studies for walleye and northern pike fed OTC medicated feed and established zero withdrawal times in juvenile northern pike and juvenile walleye at water temperatures down to 14°C and 16°C, respectively.

UMESC obtained funding for an oxytetracycline (OTC) environmental assessment (EA) from the Wallop-Breaux Sport Fish Restoration Funds on July 25, 2001. The project includes measurement of OTC in water and sediment in and around a hatchery with a typical treatment for a disease episode.

In September 2001, the Multi-State Conservation Grant Program indicated it will fund UMESC to develop data toward oxytetracycline immersion therapy.

On October 5, 2001, UMESC submitted a response to CVM regarding data to support human food safety technical section for an analytical method for oxytetracycline in the edible tissue of fish used in residue depletion studies.

Progress on Technical Sections on OTC:

Product Chemistry— Previously accepted by CVM under original NADA from Pfizer, Inc. (now owned by Phibro Animal Health).

Mammalian Safety—Previously accepted by CVM under original NADA from Pfizer, Inc. (now owned by Phibro Animal Health).

Environmental Safety—Previously accepted by CVM under original NADA from Pfizer, Inc. (now owned by Phibro Animal Health). CVM is requiring a new EA for any new label claims. UMESC is in the process of writing the EA.

Human Food Safety—Previously accepted by CVM for certain label claims under original NADA from Pfizer, Inc. for OTC for cold water species above 9EC and warm water species above 16EC. Recently, CVM accepted: (1) residue chemistry studies submitted by UMESC for use of OTC below the label claim limit of 9EC which established a withdrawal time of three days for juvenile salmonids, (2) residue depletion studies submitted by UMESC for the use of OTC in juvenile cool water species with a zero withdrawal time, (3) an HPLC method developed by UMESC to detect OTC in feed and fish tissue, and (4) a study completed by UMESC bridging the HPLC OTC detection method to the official microbial assay method. UMESC petitioned CVM to shorten the withdrawal time for OTC in all freshwater fish species based on its residue depletion data and the new tolerance of 2 ppm. Efforts on this technical section are considered complete.

Target Animal Safety—Previously accepted by CVM for catfish, salmonids, and lobsters under original NADA from Pfizer, Inc. Target animal safety studies conducted according to Good Laboratory Practice regulations are required for cool water fish because there are no adequate pivotal and supporting efficacy studies on these additional species to demonstrate that OTC is safe. UMESC has begun these studies on one coolwater species and one warmwater species.

Efficacy—Previously accepted by CVM under original NADA from Pfizer, Inc. for OTC use on catfish, salmonids and lobsters to control certain systemic bacterial diseases. CVM accepted the use of OTC at 3.75 g/100 lb of fish for 10 days as effective in reducing mortalities from: (1) systemic columnaris disease in steelhead trout and (2) systemic coldwater disease in fingerling coho salmon. The efficacy technical section developed by UMESC from a data call-in was accepted as supporting data for control of: (1) Aeromonas sp. in cool water species, and (2) systemic columnaris disease in salmonids.

UMESC researchers collaborated with the state of Iowa (Rathbun Research Facility, Moravia, Iowa) to conduct a pivotal efficacy trial to control mortalities associated with systemic columnaris disease in walleye (Stizostedion vitreum). The efficacy trial was inconclusive.

Pet Fish Therapeutants (various drugs and pesticides)—Status: Major effort to resolve non-food fish issues for these drugs through Minor Use Minor Species legislation.

Potassium Permanganate (external microbicide)—Status: Sponsor is committed to revising a product chemistry technical section.

In September 2001, the Multi-State Conservation Grant Program indicated it will fund a study on the environmental fate and effect of potassium permanganate. This study was initiated January 2002 at Arkansas State University.

HKD-SNARC completed a target animal safety study on channel catfish and plans to submit the study to CVM in 2002.

HKD-SNARC completed pivotal efficacy studies that demonstrated efficacy to prevent Ichthyophthirius sp. on channel catfish and tilapia and plans to submit the study to CVM in 2002.

The National Aquaculture NADA Coordinator met with Carus Chemical Company on February 12, 2002 to discuss the role that the company can play in the final development of potassium permanganate as an aquaculture drug.

Progress on Technical Sections on potassium permanganate:

Product Chemistry—The sponsor, Carus Chemical Company, submitted product chemistry technical section for all fish to CVM on December 8, 1998; additional data are still needed. The sponsor is in the process of providing the additional data.

Mammalian Safety—Accepted by CVM.

Environmental Safety—The sponsor submitted a request for a categorical exclusion from an environmental assessment for all fish to CVM on February 23, 1998; CVM is requiring an environmental assessment. Efforts at Arkansas State University began in January 2002 on environmental fate and effects studies with funding from the Multi-State Conservation Grant Program

Human Food Safety—Accepted by CVM.

Target Animal Safety—HKD-SNARC completed a target animal safety study on channel catfish and plans to conduct a target animal safety on rainbow trout.

Efficacy—HKD-SNARC completed pivotal efficacy studies that demonstrate efficacy to prevent Ichthyophthirius on channel catfish and tilapia. HKD-SNARC is initiating a pivotal efficacy study for control of Ichthyophthirius on channel catfish and a scaled species.

Praziquantel (trematode and cestode control)—Status: Some interest on the part of potential sponsor in a NADA approval in the United States but needs positive marketing information; has approval in several countries.

The potential sponsor of praziquantel expressed an interest in developing their product for United States aquaculture at a meeting in August 2001 in Bozeman, Montana.

The National Aquaculture NADA Coordinator met with Betty L. Mitchell, Inc. on May 17, 2001 in Stoneville, Mississippi to discuss the development of her praziquantel product.

Pyceze™ (external microbicide)—Status: Sponsor submitted an INAD/NADA letter of intent and summary of all major technical sections; met with CVM on development of data; early development stage.

Vericore Limited sold its Pyceze™ to Novartis Animal Health LTD who is interested in moving forward more rapidly in developing their product for our domestic aquaculture as stated at a meeting in August 2001 in Bozeman, Montana.

On November 1, 2001, Novartis Animal Health announced that Pyceze™ was approved in the United Kingdom for the control of fungal infections on salmonid eggs.

Quinine (internal microbicide—Status: Some interest on the part of potential sponsor in a NADA approval in the United States but needs positive marketing information.

Romet-30® (oral antibacterial)—Status: Romet-30® has limited approvals for catfish and salmonids. Early development stage for extensions and expansions.

The National Aquaculture NADA Coordinator met with the Alpharma Animal Health product manager for Romet-30® and UMESC in August 2001 in Bozeman, Montana to discuss potential extensions and expansions of the NADA for publicly cultured finfish.

The National Aquaculture NADA Coordinator met with the Alpharma Animal Health product manager for Romet-30® on April 16 and May 1-2, 2002 to develop a plan for the extensions and expansions of the NADA. Alpharma has made a commitment to expand and extend Romet-30® to other species and other diseases in the near future.

Sarafloxacin (oral antibacterial)—Status: Previously, most of the NADA technical sections were submitted by Abbott Laboratories and accepted by CVM for control of enteric septicemia in catfish with sarafloxacin. However, CDC presented concerns about the use of all fluoroquinolones in animal health because of the perceived potential for developing pathogen resistance to drugs used in humans. It is doubtful that a new NADA on sarafloxacin or any fluoroquinolone will be allowed for aquaculture uses by CVM. Sarafloxacin was replaced by florfenicol as the oral antibacterial and model drug for crop grouping research in January 1998 by a unanimous vote of the IAFWA Project stakeholders.

Sea Lice Control (various drugs and pesticides)—Status: Various drugs and pesticides (azamethiphos or Salmosan™, cypermethrin or Excis™) are being pursued by the United States and Canada and are at various stages of registration and approval.

Various drugs and pesticides (azamethiphos or Salmosan™, cypermethrin or Excis™) are being pursued by the United States and Canada and are at various stages of registration and approval. These uses are being challenged on the East coast, particularly in Maine. An INAD for Slice™ (emamectin benzoate) was allowed by CVM as a result of great need for a control that could not be challenged to the extent that the others have been.

Trichlorfon (external parasite control)—Status: Some interest on the part of potential sponsor in a NADA approval in the United States; has approvals in several countries; several Special Local Need registrations obtained in 1998 for control of predaceous insects.

The SLN registration in California is in jeopardy because the state wants more data.

AQUI-S™—Status: Sponsor (AQUI-S New Zealand Ltd.) proceeding with worldwide drug approval.

The sponsor, AQUI-S New Zealand LTD., reversed a business decision to reformulate their product. The product to be developed in the U.S. is the same formulation that the company has approved as a fish anesthetic in several countries.

At their meeting at Bozeman, MT on August 2-3, 2001, members of the DAWG verbally agreed to the redirection of UMESC Year 8 funds originally intended for efficacy and target animal safety studies to conduct studies necessary to determine the marker residue of AQUI-S™.

In September 2001, the Multi-State Conservation Grant Program indicated it will fund UMESC to develop a determinative analytical method for the marker residue for AQUI-S™.

USDA did not fund the proposal submitted by the U.S. representative of AQUI-™ for mammalian safety studies that would substitute for NTP studies.

Progress on Technical Sections on AQUI-S™:

Product Chemistry—Accepted elsewhere; no current activity for U.S.

Mammalian Safety—The sponsor (AQUI-S New Zealand Ltd.) conducted a review of the mammalian safety literature to determine whether to continue with the original active ingredient in light of National Toxicology Program (NTP) studies to test for its potential carcinogenicity. The sponsor concluded that the active ingredient is safe and presented these conclusions to CVM on November 18, 1999 and decided to proceed with the drug approval in the U.S. for original active ingredient based on their assessment of scientific data that the active ingredient is not a carcinogen.

Environmental Safety—The sponsor submitted a summary to CVM and has completed an environmental biodegradation study in freshwater and salt water that will soon be submitted to CVM for review.

Human Food Safety—Efforts are underway to develop a determinative analytical method for the marker residue at UMESC.

Target Animal Safety—Preliminary toxicity studies have been completed at UMESC on a variety of fish species but UMESC will not perform any other studies because funds were diverted to fulfill the need for human food safety studies. Pivotal target animal safety studies on salmonids will be performed at FWS. The sponsor is ready to submit target animal safety and efficacy studies on salmonids completed in Canada to CVM.

Efficacy—Preliminary efficacy studies were completed at UMESC on a variety of fish species. Pivotal efficacy studies will be performed by FWS on a variety of fish species but UMESC will not perform any other studies because funds were diverted to fulfill the need for human food safety studies. The sponsor is ready to submit efficacy studies on salmonids completed in Canada to CVM. On November 29, 2000, CVM permitted the use of AQUI-S™ under FWS’s INAD to treat up to 100 million fish with 5 to 34 mg/L AQUI-S™ in a static bath for one to ten minutes.

Benzocaine—Status: Major effort by IAFWA Project for NADA approval terminated because of decision by IAFWA Project stakeholders to select AQUI-S™ as the candidate anesthetic in the U.S. public aquaculture sector; no known drug approval activities underway.

MS-222—Status: Two approved NADAs for MS-222 as an anesthetic with a 21-day withdrawal time.

Oil of Cloves—Status: Oil of cloves (eugenol) is considered Generally Recognized as Safe (GRAS) when used as a direct food additive (21CFR184.1257); however, to use eugenol as an anesthetic on fish, it must be approved by CVM for that purpose. A sponsor is required to proceed toward approval and no sponsor has come forward; no known drug approval activities underway.

Common Carp Pituitary (CCP)—Status: Sponsor and interested parties proceeding toward NADA approval. All submissions should be completed in 2001 for use on all fish.

Mississippi State University submitted a target animal safety study on grass carp to CVM. Funding has been requested from NRSP-7 to do research on walleye, catfish, and white bass.

Progress on Technical Sections on CCP:

Product Chemistry—The sponsor submitted the product chemistry technical section for CCP to CVM on September 21, 1999. The sponsor received a response on November 22, 1999 from CVM that asked for more information

Mammalian Safety—Accepted by CVM.

Environmental Safety—Accepted by CVM.

Human Food Safety—Accepted by CVM.

Target Animal Safety—A literature review on target animal safety of CCP was completed, presented on August 5, 1998 in Bozeman, Montana and submitted to CVM in summer 1999 by the Southeastern region of NRSP-7. A researcher from Mississippi State University completed target animal safety studies on CCP and submitted them to CVM.

Efficacy—A literature review on efficacy of CCP was completed, presented on August 5, 1998 in Bozeman, Montana and submitted to CVM in summer 1999 by the Southeastern region of NRSP-7.

17 β-estradiol (estrogen)—Status: Sponsor established INAD #10-673) and had a meeting with CVM to determine data requirements; early development stage.

Human Chorionic Gonadotropin (hCG)—Status: September 1999 NADA approval in the United States.

Chorulon® (human chorionic gonadotropin) was approved on September 7, 1999 by CVM as a spawning aid by intramuscular injection for all fish and requires a prescription under the direction of a veterinarian. This approval is significant because it is the first original NADA approval since 1986 when formalin was first approved for fish and because it was approved for all fish.

17 α-methyltestosterone (MT)—Status: Sponsor is developing NADA package; INAD sponsors actively pursuing a NADA approval; environmental assessment reviewed, revised, and resubmitted.

Environmental Safety—Auburn University is working on a response to comments by CVM on the environmental assessment that they wrote on the use of MT for tilapia. It has been determined that an environmental study is needed and Auburn has secured a USDA laboratory to do the study. Auburn developed a study protocol that they submitted on October 4, 2001 to CVM for review and acceptance.

Target Animal Safety—Auburn is working on a TAS technical section for tilapia. Southern Illinois University (SIU) completed a TAS study on percids that was funded by NCRAC and reviewed by CVM. The TAS study was found to be inadequate by CVM; SIU needs to respond to the comments by CVM to resolve the issues so that the technical section can be declared complete for percids by CVM.

Efficacy—Auburn is working on a technical section to complete it for tilapia. The University of Wisconsin is working on developing the efficacy technical section for percids.

The National Aquaculture NADA Coordinator met at Aquaculture America 2002 with the sponsor of MT and Auburn University to determine a course of action for: (1) product chemistry, (2) environmental safety, (3) efficacy, and (4) target animal safety.

Progress on Technical Sections on MT:

Product Chemistry—The sponsor, Rangen, Inc., submitted a product chemistry technical section on 17 α-methyltestosterone to CVM on November 8, 2000. CVM is requiring more information.

Mammalian Safety—Accepted by CVM.

Environmental Safety—Auburn University received a response from CVM on November 8, 1999 regarding the revised environmental assessment for MT that requested additional information; met on July 18, 2000 to discuss response; efforts to meet the remaining data requirements in this technical section will be made by the Aquatic Animal Health Research Unit in Auburn, Alabama..

Human Food Safety—Accepted by CVM.

Target Animal Safety—CVM found a target animal safety study on percids by Southern Illinois University to be inadequate; literature review on other species completed by Auburn University.

Efficacy Auburn University is coordinating a compassionate INAD on tilapia; North Central Regional Aquaculture Center representatives are coordinating a compassionate INAD on percids.

Ovaplant™ and Ovaprim™—Status: Sponsor recently submitted INAD letter of intent; early development stage.

ReproBoost™ (Gonadotropin Releasing Hormone)—Status: Sponsor recently submitted INAD letter of intent; early development stage.

Calcein—Status: Have sponsor; Early development stage.

The National Aquaculture NADA Coordinator met with the sponsor, FWS, and CVM at Aquaculture America 2002 to discuss the development of calcein for approval and has helped the sponsor with literature searches.

Oxytetracycline—Status: Public Master File from NRSP-7 accepted by CVM

On May 21, 2002, CVM accepted the Public Master File for the use of oxytetracycline immersion for skeletal marking of fry and fingerling finfish. CVM will publish a notice in the Federal Register that this use is approved and will invite sponsors to apply for an NADA or supplemental NADA.

Strontium Chloride—Status: Western Chemical Inc. is the sponsor; some work completed in Alaska; some efficacy studies underway under Western NRSP-7.

PISCICIDES—Both rotenone and antimycin are used by hatcheries in resource agencies and private aquaculture facilities to control diseases in cultured fish and undesirable fish in ponds.

The National Aquaculture NADA Coordinator hosted a meeting of the American Fisheries Society Fish Management Chemicals Subcommittee (FMCS) at La Crosse, Wisconsin on May 31 to June 3, 2001 to discuss the development of reregistration feasibility on antimycin and a rotenone use survey.

The National Aquaculture NADA Coordinator met with EPA on November 15, 2001 to discuss the revised data requirements for the reregistration of antimycin based on a draft study report that was completed by FMCS.

The FMCS met on November 16-17, 2001 to discuss the development of a mechanism to maintain the registration of antimycin and the remaining activities on rotenone.

The Drug Approval Working Group (DAWG) for the Federal-State Aquaculture Drug Approval Partnership Project (IAFWA Project) held a meeting in Bozeman, Montana on August 2-3, 2001 to: (1) discuss the progress being made on the IAFWA Project drugs, (2) work plans for the final year of the IAFWA Project, (3) discuss new funding proposals on florfenicol, AQUI-S™, disease model for external columnaris disease, and environmental assessment for oxytetracycline, and (4) the future of public drug approval efforts after 2002.

The DAWG had two other meetings during this period of time–December 4, 2001 in Wichita, Kansas and April 4, 2002 in Dallas, Texas. At the Wichita meeting, several action items were developed. Listed below are those action items and the response:

Roz Schnick and Bill Gingerich–request a meeting in February 2002 with CVM regarding the data gaps for the remaining technical sections. Such a meeting was held March 14, 2002.

Roz Schnick–write a letter to CVM requesting a high-level meeting before the April DAWG meeting but after the technical section meeting to discuss progress and impediments to approvals for IAFWA Project drugs. It was decided by the DAWG that a letter should be written instead. The National Aquaculture NADA Coordinator wrote a draft letter that was finalized and signed by Bob Miles on March 6, 2002.

Roz Schnick–develop a brief survey of the states on their priority label claims for the eight IAFWA Project drugs. The National Aquaculture NADA Coordinator sent out a survey to the states on December 27, 2001. Results were analyzed and presented at the meeting in Dallas on April 4, 2002.

Dave Erdahl and Roz Schnick–obtain and compile annual fish production figures for each state for information to be sent to sponsors and potential sponsors. The National Aquaculture NADA Coordinator sent surveys on December 28, 2002 to all 50 states and followed up with another mailing on February 9, 2002. The Bozeman NIO is collating the responses into a database.

Celebration Steering Committee (Bob Miles, Doug Hanson, Roz Schnick, and Dave Erdahl)–plan the celebration of the success of the IAFWA Project. The Celebration Luncheon is set for September 18, 2002 at Big Sky, Montana. Doug Hanson coordinated a series of conference calls in April and May 2002. The National Aquaculture NADA Coordinator prepared lists of invitees and awardees, wrote a brochure, arranged for a speaker, and contacted and secured sponsors for the event.

Bill Gingerich–draft letter to Mike Gibson to support Roz Schnick’s position from May to September 2002 based a her budget needs for coordinating the IAFWA Project during that time. The National Aquaculture NADA Coordinator provided information on a budget to Bill Gingerich.

Bob Miles and Bill Gingerich–obtain radiolabeled AQUI-S™ in an expeditious manner through IAFWA, thus by-stepping the Federal Register notice. UMESC was able to obtain the material without assistance from IAFWA.

Roz Schnick–distribute the DAWG minutes from the August 2001 meeting in Bozeman by December 18, 2001. The National Aquaculture NADA Coordinator sent out the final minutes on December 17, 2001.

Bob Miles–draft letters to USGS, USDA, and FWS for Max Peterson’s signature to indicate the great job that UMESC, HKD-SNARC, and Bozeman have done on the IAFWA Project drugs. No known action.

Bob Miles and Doug Hanson–plan the April 2002 meeting of the DAWG to be held in Dallas, Texas. Meeting was held April 4, 2002.

Follow-up items to the Dallas meeting are as follows:

Follow-up to fish production survey. The National Aquaculture NADA Coordinator worked with Dave Erdahl to determine which states have not responded and informed Mike Gibson. Dave Erdahl is contacting the remaining states for the production data.

Current status of the Technical Sections for IAFWA Project drugs–UMESC volunteered to clarify the status with new graphics.

Remaining funds available for the IAFWA Project—USGS offered to provide the final figures for the funds available form the states for the remaining data gaps at the FWS INAD Workshop in August 2002.

Prioritization of unmet label claim needs. The National Aquaculture NADA Coordinator prepared an assessment of the major unmet label claim needs for the control of external bacterial infections on cool water and warm water species on April 7, 2002 and for oral drugs on April 15, 2002.

Clarification of the projected status of label claims—The National Aquaculture NADA Coordinator provided such a clarification on April 8, 2002.

MUMS status--The National Aquaculture NADA Coordinator provided the most current status of the Minor Use Minor Species legislation to the DAWG on April 13, 2002.

Next DAWG meeting—Bob Miles and Mike Gibson scheduled a meeting of the DAWGs for the morning of August 2, 2002 in Bozeman, Montana.

Funds from state contributions for Program Manager of the IAFWA Project (i.e., the National Aquaculture NADA Coordinator)—The National Aquaculture NADA Coordinator provided a budget to Mike Gibson for FY 2003 with a copy to Bob Miles on April 7, 2002.

Status of diquat development—The National Aquaculture NADA Coordinator provided the current situation regarding diquat to the DAWGs on April 7, 2002 and contacted the company on April 8, 2002 concerning the support of an approval for diquat by the DAWGs.

An article addressing aquaculture and drug resistance was written by Randy MacMillan and published in the June 2001 issue of World Aquaculture.

On November 2-4, 2001, the American Academy of Microbiology convened a colloquium entitled "The role of antimicrobials in agriculture: A critical scientific assessment". Four experts on aquaculture provided input for a report to be presented to CVM in June 2002 that will indicate a lack of a problem.

CVM accepted the oxytetracycline letter on antimicrobial resistance for use as a marking agent, setting a precedent for aquaculture drugs. CVM also stated in a meeting on March 14, 2002 that both hydrogen peroxide and chloramine-T were considered to be safe regarding this issue.

The Joint Subcommittee on Aquaculture formed the Aquaculture Effluents Task Force (AETF) to coordinate and facilitate input of science-based information to assist in the development of national effluent limitation guidelines and standards for aquaculture facilities by EPA. The AETF met on October 17-18, 2001 to discuss the status of EPA’s Effluent Guidelines Plan for aquaculture facilities. A conference call was convened on May 30, 2001 to discuss drug and chemical issues with EPA and a response was prepared after a conference call on October 11, 2001 with AETF members.

The latest meeting of the AETF was held on January 27, 2002. The purpose of the meeting was to discuss the status of EPA’s Effluent Guidelines Plan for aquaculture facilities. The latest direction that EPA plans to go are Best Management Practices for drugs and chemicals; however, recent attempts at gaining a discharge permit from EPA in Maine have illustrated that INADs and extra label use would not be allowed. The National Aquaculture NADA Coordinator wrote a response to this extreme proposed permit in Maine and interacted with CVM on this issue.

A bill entitled "Minor Animal Species Health and Welfare Act of 2000" was introduced in the U.S. Congress into the House on June 27, 2000 (HR-4780) and into the Senate on October 5, 2000 (S-3169). The MUMS Act will facilitate and accelerate the approvals of aquaculture drugs. The bill includes provisions for early life stages that should help expedite the approvals of aquaculture drugs that are of interest to public and private fish production.

A revised bill "Minor Use Minor Species Animal Health Act of 2001" was reintroduced into the House on May 24, 2001 (HR-1956) and into the Senate on August 2, 2001 (S-1346). The MUMS Coalition met on June 22, 2001 to coordinate the legislative effort on the bill, present information to legislative staff, and contact individual congressmen and senators for their support and sponsorship.

The MUMS bill was attached to the Bioterrorism Bill but it was removed from the bill shortly before its passage on May 22, 2002. The MUMS bill picked up supporters and hope to attach it to the "Animal Drug User Fee Act of 2002."

A session on international harmonization of sensitivity testing was held at the EAFP 9th International Conference, September 19-24, 1999 in Rhodes, Greece. A follow-up session was held in Dublin, Ireland in September 2001. The EAFP Work Group is working with the National Committee for Clinical Laboratory Standards to develop protocols that will allow aquatic diagnostic and research laboratories to: (1) test disease-associated bacterial isolates for antimicrobial susceptibility patterns and (2) recommend appropriate therapy in a standard, internationally accepted manner. Added benefits include aiding the approval process for antibacterial agents and helping to determine the antimicrobial resistance of aquaculture pathogens worldwide. CVM’s Office of Research is conducting studies to help with the standardization of these sensitivity tests.

The National Aquaculture NADA Coordinator wrote a document submitted by the Catfish Farmers of America that stated there should be no difference between domestic and foreign requirements to ensure safety and fair competition.

CVM awarded a contract on the risk assessment of drugs and chemicals used in foreign aquaculture on September 28, 2001 to ICF Consulting. The objectives of this contract are to: (1) create a database containing information on drug and chemical use is foreign aquaculture and (2) perform a human food safety risk assessment for each drug and chemical listed in the database. FDA will use the results of this contract to: (1) prioritize the monitoring of drug and chemical residues in the edible tissue of imported aquaculture products, (2) prioritize the development of methods to be used in the monitoring program, and (3) provide a basis for promoting discussion with foreign countries regarding the hazard concerns identified by the risk assessment. The National Aquaculture NADA Coordinator is a subcontractor to this project and provided information to FDA regarding drug use (especially chloramphenicol) in shrimp and basa (i.e., Vietnamese catfish) production.

On August 2-3, 2001, nine sponsors or potential sponsors invited by the National Aquaculture NADA Coordinator attended a meeting of the Federal-State Aquaculture Drug Approval Partnership Project. These sponsors were interested in the development of their products for aquaculture. These sponsors included the major pharmaceutical firms of Alpharma, Bayer, Intervet, Novartis, and Schering-Plough and chemical or niche companies of Akzo Nobel Chemicals Inc., AQUI-S New Zealand LTD, Phelps Dodge Refining Corporation, and Carus Chemical Company.

Schnick, R.A. 2001. International harmonization of antimicrobial sensitivity determination for aquaculture drugs. Aquaculture (3-4):277-288.

Schnick, R.A. 2001. Progress of the Federal-State Aquaculture Drug Approval Partnership Project. American Fisheries Society Fish Health Newsletter 29 (4):6-7, 9.

Schnick, R.A. 2001. Aquaculture chemicals. Online Chapter in Kirk-Othmer Encyclopedia. John Wiley & Sons, Inc., New York, New York. 27 pp.

Schnick, R.A. 2001. New drug availability. Aquaculture Medicine Educational Program, AVMA Convention 2001, Boston, Massachusetts, July 14-16, 2001.

Schnick, R.A. 2001. Overview of progress toward aquaculture drug approvals. USFWS–7^th Annual INAD Coordination Workshop, Bozeman, Montana, August 1-3, 2001.

Schnick, R.A. 2001. Update on the activities of the National Coordinator for Aquaculture New Animal Drug Applications. NRSP-7 Fall Meeting, Rockville, Maryland, October 22-23, 2001.

Schnick, R.A. 2001. Update on Project activities/progress. Drug Approval Working Group Meeting, Wichita, Kansas, December 4, 2001.

Schnick, R.A. 2001. Diquat dibromide potential in aquaculture. Syngenta Crop Protection, Inc., Greensboro, North Carolina, December 18, 2001.

Schnick, R.A. 2002. Managing crop health. Striped Bass Growers Industry Forum, Aquaculture America 2002, San Diego, California, January 27-30, 2002.

Schnick, R.A. 2002. Welcome/highlights and progress in aquaculture drug approvals. Special Session: Successes and Challenges to the Aquaculture Drug Approval Process, Aquaculture America 2002, San Diego, California, January 27-30, 2002.

Schnick, R.A. 2002. National Aquaculture NADA Coordinator activities. Working Group on Quality Assurance in Aquaculture Production, Aquaculture America 2002, San Diego, California, January 27-30, 2002.

Schnick, R.A. 2002. Progress toward approval of potassium permanganate. Carus Chemical Company, Peru, Illinois, February 12, 2002.

Schnick, R.A. 2002. Overall status report on aquaculture drugs. North Central Regional Aquaculture Center, Board of Directors and 2002 Program Planning Meeting, St. Louis, Missouri, February 15-17, 2002.

Schnick, R.A. 2002. Update on Project activities/progress. Status of IAFWA Project drugs and unmet label claims in September 2002 and September 2003. Issues concerning individual drugs - AQUI-S, chloramine-T, florfenicol and the need for broad approval of all drugs. Report on action items from December 4, 2001 meeting, Dallas, Texas, April 4, 2002.

Schnick, R.A. 2002. Update on the activities of the National Coordinator for Aquaculture New Animal Drug Applications, National Research Support Program Number Seven (NRSP-7), Spring Meeting, Davis, California, April 29-30, 2002.

Schnick, R.A. 2001. National Coordinator for Aquaculture New Animal Drug Applications (NADAs). Sixth annual report of activities, May 15, 2000 to May 14, 2001. Submitted to Ted Batterson, North Central Regional Aquaculture Center, East Lansing, Michigan. June 15, 2001. 18 pp.

Schnick, R.A. 2001. Notes on conference call regarding AQUI-S™ on June 5, 2001, 2:45 PM. Submitted to participants in conference call, La Crosse, Wisconsin. July 10, 2001. 2 pp.

Schnick, R.A. 2001. 2001 annual report of the AFS Task Force on Fishery Chemicals. Submitted to the Governing Board and AFS President, Carl Burger, Bethesda, Maryland. July 18, 2001. 4 pp.

Gingerich, W.H., R.A. Schnick, and B.R. Griffin. 2001. Approval of Drugs for Public Fish Production: Grant proposal for Project Year 8. Biological Resources Division, USGS, Upper Midwest Environmental Sciences Center, La Crosse, Wisconsin. July 26, 2001. 13 pp.

Schnick, R.A. 2001. OTC: Federal-State Aquaculture Drug Approval Partnership Project. Submitted to Gregory Bergt, PennField Animal Health, La Crosse, Wisconsin. August 21, 2001. 2 pp.

Schnick, R.A. 2001. Estimated costs for studies to be performed at the Upper Midwest Environmental Sciences Center, La Crosse, Wisconsin (as of August 2001). Submitted to pharmaceutical firm (confidential). August 23, 2001. 2 pp.

Schnick, R.A. 2001. Rankings of proposals for Multi-State Conservation Grant Program–August 2001. Submitted to IAFWA representatives. August 29, 2001. 5 pp.

Schnick, R.A. 2001. Comments on import tolerances. Submitted to the Catfish Farmers of America, Indianola, Mississippi. September 5, 2001. 2 pp.

Gingerich, W.H., V.K. Dawson, G.R. Stehly, J.A. Bernardy, M.P. Gaikowski, J.R. Meinertz, J.J. Rach, L.J. Schmidt, C. Vue, R.A. Schnick, and B.R. Griffin. 2001. Approval of Drugs for Public Fish Production: Seventh annual report of progress [performance period: July 1, 2000 to June 30, 2001]. Biological Resources Division, USGS, Upper Midwest Environmental Sciences Center, La Crosse, Wisconsin. September 14, 2001. 50 pp.

Schnick, R.A. 2001. Diquat dibromide potential in aquaculture. Submitted to Syngenta Crop Protection, Inc., Greensboro, North Carolina. October 3, 2001. 3 pp.

Schnick, R.A. 2001. Status of technical sections for joint minor use/minor species drug approvals coordinated through the National Aquaculture NADA Coordinator and NRSP-7 as of October 22, 2001. Submitted to NRSP-7, Rockville, Maryland. October 22, 2001. 5 pp.

Drugs and Chemicals Technical Subgroup, Aquaculture Effluents Task Force, Joint Subcommittee on Aquaculture. 2001. Response to EPA (Tetra Tech) August 14, 2001 summary of telephone conference and attachments. Submitted to EPA. October 16, 2001. 5 pp.

Schnick, R.A. 2001. Progress report for Contract #99-116 (National Coordinator for Aquaculture New Animal Drug Applications). Center for Tropical and Subtropical Aquaculture, Waimanalo, Hawaii. October 25, 2001 (revised November 9, 2001). 9 pp.

Schnick, R.A. 2001. Confidential: Minutes to meeting on genotoxicity studies on p-TSA, the marker residue of chloramine-T with the Center for Veterinary Medicine and Akzo Nobel Chemicals, Inc. representing Axcentive bv. Submitted to Akzo Nobel Chemicals, Chicago, Illinois. November 5, 2001. 5 pp.

Schnick, R.A. 2001. National Coordinator for Aquaculture New Animal Drug Applications (NADAs). Seventh mid-year report of activities, May 15, 2001 to November 9, 2001. Submitted to Ted Batterson, North Central Regional Aquaculture Center, East Lansing, Michigan. November 21, 2001. 16 pp.

Schnick, R.A. 2001. Minutes to Drug Approval Working Group Meeting,, Bozeman, Montana, August 2-3, 2001. Submitted to Drug Approval Working Group. December 17, 2001. 11 pp.

Schnick, R.A. 2001. Minutes to Drug Approval Working Group Meeting, Wichita, Kansas, December 4, 2001. Submitted to Drug Approval Working Group. December 27, 2001. 9 pp.

Schnick, R.A. 2001 and 2002. State fish production data needed. Sent to 50 state fish chiefs. December 28, 2002. 2 pp.; follow up request to 21 states on March 23, 2002.

Schnick, R.A. 2002. Termination report for Contract #99-116 (October 1, 1996 through October 1, 2001). Submitted to the Center for Tropical and Subtropical Aquaculture, Waimanalo, Hawaii. February 7, 2002. 12 pp.

Schnick, R.A. 2002. 2002 mid year report of the AFS Task Force on Fishery Chemicals. Submitted to the Governing Board and AFS President, Ken Beal, Bethesda, Maryland. February 9, 2002. 4 pp.

Schnick, R.A. 2002. Progress toward approval of potassium permanganate (status as of February 12, 2002). Submitted to Carus Chemical Company, Peru, Illinois. February 10, 2002. 4 pp. plus 10 attachments.

Schnick, R.A. 2002. Status of 17%methyltestosterone (MT) technical sections for a NADA approval for both tilapia and percids. Submitted to Ted Batterson, North Central Regional Aquaculture Center, East Lansing, Michigan. February 14, 2002. 2 pp.

Gingerich, W.H., V.K. Dawson, G.R. Stehly, J.A. Bernardy, M.P. Gaikowski, J.R. Meinertz, J.J. Rach, L.J. Schmidt, C. Vue, R.A. Schnick, and B.R. Griffin. 2002. Approval of Drugs for Public Fish Production: Executive summary of the eighth midyear report of progress [performance period: July 1, 2001 to December 31, 2001]. Biological Resources Division, USGS, Upper Midwest Environmental Sciences Center, La Crosse, Wisconsin. February 20, 2002. 11 pp.

Schnick, R.A., and M. Hathaway. 2002. Comments by the Catfish Farmers of America on import tolerances. Submitted to Catfish Farmers of America for forwarding to the U.S. Food and Drug Administration, Rockville, Maryland. February 21, 2002. 4 pp.

Schnick, R.A. 2002. Assessment on the status of aquaculture drugs (as of March 1, 2002). Submitted to Joan Gotthardt, CVM, Rockville, Maryland. March 2, 2002. 4 pp.

Schnick, R.A. 2002. Comments on applicability of effluent guideleines: description of options for each method of aquaculture production as they relate to drug and chemical use. Submitted to Gary Jensen, Chair, Aquaculture Effluents Task Force, Washington, DC, for forwarding to the U.S. Environmental Protection Agency. March 4, 2002. 2 pp.

Schnick, R.A. 2002. Final unmet label claim needs. Submitted to IAFWA participating states and the Drug Approval Working Group. March 11, 2002. 3 pp.

Schnick, R.A. 2002. Letter to Dr. Steve Sundlof, CVM Director concerning the IAFWA Project. Submitted to IAFWA for transmittal to CVM, Rockville, Maryland. March 6, 2002. 3 pp.

Schnick, R.A. 2002. Status of public sector label claim needs - April 4, 2002. Submitted to Drug Approval Working Group. April 4, 2002. 4 pp.

Schnick, R.A. 2002. Analysis of major unmet label claim needs. Submitted to Drug Approval Working Group. April 7, 2002. 3 pp.

Schnick, R.A. 2002. Follow-up to April 4, 2002. Submitted to Drug Approval Working Group. April 8, 2002. 2 pp.

Schnick, R.A. 2002. Unmet label claims for systemic bacterial diseases. Submitted to Drug Approval Working Group. April 15, 2002. 3 pp.

Schnick, R.A. 2002. Minutes to Drug Approval Working Group Meeting,, Dallas, Texas, April 4, 2002. Submitted to Drug Approval Working Group. May 8, 2002. 8 pp.

 The National Coordinator for Aquaculture New Animal Drug Applications is attempting to carry out these goals and objectives through this web site. Please use the e-mail address, RozSchnick@centurytel.net  , to contact her for input and questions.

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